Withdrawal of marketing authorisations for fenspiride medicines

May 17, 2019 – EMA’s safety committee (PRAC) has recommended that the marketing authorisations for fenspiride medicines be revoked, so the medicines can no longer be marketed in the EU. This follows a review that has confirmed that these cough medicines could cause heart rhythm problems. The PRAC considered all the available evidence in its review. This included cases of QT prolongation and torsades de pointes (abnormalities of the heart’s electrical activity that … (leggi tutto)